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    Senior Manufacturing Engineer - Ellettsville, United States - Cook Medical

    Cook Medical
    Cook Medical Ellettsville, United States

    3 weeks ago

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    Description
    Overview

    The Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner.

    The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.

    Responsibilities


    • Possess the ability to manage multiple complex projects with a high level of detail and accuracy
    • Ability to work hands on with critical equipment/systems
    • Adhere to Quality Management System to ensure meetring FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements,driving quality throughout the organization
    • Troubleshoot mechanical/electrical/pneumatic equipment and processes and provide direction to maintenance staff for equipment fixes
    • Identify opportunities for process improvements and drive project work
    • Acts as a resource for all operational departments for equipment support and process upgrades
    • Perform validation and qualification activities on equipment and processes
    • Ensure new or modified asset information is properly transferred into Maintenance and Calibration systems
    • Ability to read and comprehend blueprints, specifications and sketches and develop/modify CAD drawings for facility, equipment, andsystems
    • Write/modify facilities equipment/systems and manufacturing equipment documents and procedures
    • Provide support to the calibration department in writing/performing calibration procedures
    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
    • Must strictly adhere to safety requirements.
    • Maintain regular and punctual attendance.
    • Must maintain company quality and quantity standards.
    • Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.
    • Ability to remain calm and receptive in fast paced situations.
    Qualifications

    • Bachelor's Degree in Engineering, preferrably Electrical Engineering
    • Experience troubleshooting/programming PLCs, PLC interface configurations, and HMIs preferred
    • 5+ years of Engineering experience, preferrably in medical device manufacturing
    • Experience with Sterilization systems/equipment is a plus
    • Works under general office environmental conditions.
    • Sitting for extended periods, utilizes close visual acuity for working withcomputers, equipment, etc.
    • Frequently required to stand, walk, and communicate.
    • Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA
    **Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
    Requisition ID
    Posting Date2 months ago(3/4/2024 9:20 AM)
    Job Location(s) Ellettsville IN United States
    Position Type Full Time
    Company Cook Inc - Ellettsville
    Category Engineering
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